On September 30, 2026 Immunome, Inc. (Nasdaq: IMNM), a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IM-1340, a potential first-in-class antibody-drug conjugate (ADC) for the treatment of advanced solid tumors.
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IM-1340 is designed to target a transport receptor with a unique tumor expression profile spanning solid tumors, including neuroendocrine tumors, lung cancer, and colorectal cancer. It incorporates HC74, Immunome’s proprietary topoisomerase I (TOP1) inhibitor payload. Preclinical studies demonstrated encouraging anti-tumor activity across multiple tumor models, supporting the decision to advance this program into clinical development.
"IND clearance for IM-1340 marks another milestone in the advancement of Immunome’s ADC platform and demonstrates our ability to rapidly progress novel HC74-based programs into the clinic," said Clay Siegall, Ph.D., President and Chief Executive Officer of Immunome. "We believe IM-1340 has the potential to treat multiple solid tumor types by combining a differentiated target with the favorable properties of our proprietary HC74 payload. We look forward to initiating clinical evaluation of IM-1340 and continuing to expand our ADC pipeline."
The Phase 1 study, which Immunome expects to initiate in the fourth quarter of 2026, is an open-label, multicenter dose-escalation and expansion trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of IM-1340 in patients with advanced solid tumors.
About IM-1340
IM-1340 is a potential first-in-class ADC incorporating Immunome’s proprietary HC74 topoisomerase I inhibitor payload. The investigational therapy targets a transport receptor with expression across solid tumors, including neuroendocrine tumors, lung cancer, and colorectal cancer. In preclinical studies, IM-1340 demonstrated anti-tumor activity, including tumor regressions following a single dose in multiple in vivo models.
(Press release, Immunome, SEP 30, 2026, View Source [SID1234671201])